Hypertensive Disorder of Pregnancy
Conditions
Keywords
Hypertension, Pregnancy, Preeclampsia, HDP
Brief summary
The goal of this interventional study is to learn from patients and healthcare providers at 4 health institutions (study sites) in Abuja and Kano in Nigeria what ways to best develop the content of a Hypertensive Disorders of Pregnancy ( HDP) Management package for pregnant women, and evaluate the effectiveness of implementing this package in improving cardiovascular health of pregnant women. The main question it aims to answer is: Will a contextualized home BP monitoring program lead to better BP control among patients with HDP in Nigeria?
Detailed description
This study aims to contextualize, implement, and evaluate the feasibility, fidelity, and acceptability and effectiveness of: 1) postpartum remote blood pressure monitoring, 2) patient education, 3) development of a standardized postpartum follow-up protocol, and 4) provision of free and/or subsidized antihypertensive medications for patients with HDP in University of Abuja, Murtala Muhammad Specialist Hospital, National Hospital, Abuja and Aminu Kano Teaching Hospital all in Nigeria. These components collectively make up a contextualized postpartum BP monitoring program called the HDP Implementation Bundle. The long-term objective is to implement a contextualized and acceptable evidence-based postpartum home BP monitoring program with supporting services and components, at 4 tertiary care institutions in Nigeria, to improve postpartum BP control in patients with HDP using a multilevel approach.
Interventions
OTHERHypertension Disorders of Pregnancy (HDP) Implementation Bundle
The HDP Implementation Bundle will consist of 4 main blocks namely; patient education, home BP monitoring, a contextualized follow-up protocol and provision of free anti-hypertensives if need. Collectively, these will lead to design and development of a contextualized home BP monitoring program.
Sponsors
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Type 1 hybrid stepped-wedge cluster randomized trial to assess if the utilization of the HDP Implementation Bundle will improve postpartum BP among women with HDP in Nigeria. Randomization will be done at cluster level and sites will begin in control and cross over to intervention phase
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Postpartum adults (\>18 years) * postpartum emancipated minors (in accordance with the Nigerian guidelines for young persons' participation in research and reproductive health services) * with diagnosis of HDP prior to delivery delivered at one of the participating sites able to provide informed consent.
Exclusion criteria
* unable to provide consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between group difference in change in systolic BP from baseline to 6-week follow-up | Baseline to 6 weeks | The change in systolic BP from baseline to 6-week follow-up between the intervention and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between group differences in change in diastolic BP at 6 weeks follow-up and change in both systolic an diastolic BP at 12 weeks | Baseline to 6(and 12) weeks | The change in diastolic BP from baseline to 6-week follow-up between the intervention and control groups. |
| Between group differences in systolic and diastolic BP at 12 weeks follow-up | Baseline to 12 weeks | The change mean systolic and diastolic BPs 12 weeks follow-up between the intervention and control group |
Countries
Nigeria
Contacts
CONTACTDike Ojji, MBBS, PhD
CONTACTKamilu Karaye, MBBS, PhD
PRINCIPAL_INVESTIGATORZainab Mahmoud, MD, MSc
Washington University School of Medicine
Outcome results
None listed